Device Recall Varta EasyPack XL Lithium Polymer Battery (PoLiFlex)

  • 모델명 / 제조번호(시리얼번호)
    Batteries coded: XX07 and earlier The Nova Biomedical products that contain the lithium batteries include the following part numbers: Part # 41772 - Battery Assy,  Part # 42215 - Battery Replacement pack,  Part # 42224 - Kit Meter,  Part # 43735 - Kit Meter EZ CHEM,  Part # 43773 - Kit Meter,  Part # 43811 - Battery Replacement Pack EZ CHEM,  Part # 44013 - Kit Meter,  Part # 44014 - Kit Meter and Part # 44251 - Kit Meter.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Canada, Taiwan, Hungary, Malaysia, Australia, Russia, Thailand, New Zealand, Austria, France, Germany, UK, China, South Africa, Croatian, Peru, and Czech Republic.
  • 제품 설명
    Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) || Used with: || Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453-3457
  • 제조사 모회사 (2017)
  • Source
    USFDA